Quality Assurance Manager

2 weeks ago


Arlington Heights, Illinois, United States Argon Medical Devices Inc Full time
Quality Assurance Manager

Argon Medical Devices Inc is seeking a Quality Assurance Manager to join our team. As a key member of our quality team, you will be responsible for ensuring the quality of our medical devices and ensuring compliance with regulatory requirements.

Key Responsibilities:

  • Develop and implement quality strategies to support customer needs and business objectives
  • Provide solutions to difficult problems relating to quality aspects of design, validation, and manufacture of medical devices
  • Manage supplier quality, customer feedback, process control, internal audits, change management, and design control
  • Serve as management representative for regulatory inspections and responsible engineering manager
  • Implement systems for product quality standards and procedures, including in-coming material quality, in-process product quality, and out-going product quality plans
  • Perform Adverse Event Evaluation and manage QA staff to ensure compliance with all Argon and government regulatory/statutory requirements

Requirements:

  • Bachelor's degree in science, math, or engineering discipline
  • CQA or CBA or RABSQA, CQE certifications required; CQMgr/OE, Lean, CSSGB/CSSBB certifications preferred
  • Minimum years of work experience in regulated healthcare environment
  • Experience in transfer of design to manufacturing, including coordination with sister companies
  • Strong validation/verification skills for equipment and processes
  • Experience with PFMEA/FMEA and ISO 14971 Risk Management
  • Measurement Systems Analysis, Gage R&R, and development of inspection test methods
  • Previous success leading and mentoring a team in a collaborative environment
  • Strong analytical and problem-solving skills
  • Ability to prioritize for maximum results (multi-task management)
  • Function successfully in a high-paced results-oriented team environment
  • Self-motivated, quick learner, productive team member
  • Excellent communication skills (verbal and written)


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